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A Proof of Concept Top Evaluate a Novel Penile Lengthening Protocol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04231422
Recruitment Status : Unknown
Verified January 2020 by Judson Brandeis, BrandeisMD.
Recruitment status was:  Recruiting
First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Judson Brandeis, BrandeisMD

Study Description
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Brief Summary:
The objective of this study is to examine and quantify the efficacy and safety of a new treatment protocol using platelet-rich plasma for penile length enhancement.

Condition or disease Intervention/treatment
Penile Elongation Combination Product: Platelet-rich plasma

Study Design
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Proof of Concept Top Evaluate a Novel Penile Lengthening Protocol
Actual Study Start Date : November 12, 2019
Estimated Primary Completion Date : May 12, 2021
Estimated Study Completion Date : July 12, 2021
Groups and Cohorts
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Group/Cohort Intervention/treatment
Treatment Group
Monthly intracavernosal platelet-rich plasma injection + daily physical manipulation.
 Combination Product: Platelet-rich plasma
12mL of platelet-rich plasma injected into cavernosal bodies bilaterally


Outcome Measures
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Primary Outcome Measures :
  1. Stretched penile length [ Time Frame: baseline to six months ]
    Change in length of stretched, flaccid penile length


Secondary Outcome Measures :
  1. SHIM Score [ Time Frame: baseline to six months ]
    Change in erectile function

  2. BDD-YBOCS [ Time Frame: baseline to six months ]
    Change in body dysmorphia scale

  3. Safety Measurement [ Time Frame: baseline to six months ]
    Incidence of adverse events and serious adverse events


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Study participants comprised of men with a desire for penile elongation.
Criteria

Inclusion Criteria:

  1. Stretched penile length between 3.5 - 8.0 in
  2. Age 20-55 years of age
  3. Desire penile length elongation
  4. Willing to complete all aspects of combined treatment plan
  5. Able to measure erect penile length and mid-shaft girth at 1-month intervals
  6. Judged to be in good health based on medical history, physical exam, and laboratory profile
  7. Is willing and able to cooperate with the requirement of the study (e.g. completion of all planned study visits)

Exclusion Criteria:

  1. No prior surgical Peyronie's disease treatment
  2. No chordee with or without hypospadias
  3. No infiltration by benign or malignant mass
  4. No active STD
  5. No infiltration by an infectious agent such as lymphogranuloma venereum
  6. No uncontrolled psychiatric conditions
  7. No uncontrolled neurologic conditions
  8. No other uncontrolled medical conditions such as HTN or DM
  9. No history of spontaneous priapism
  10. Is unable to safely use the study devices as determined by the principal investigator
  11. No thrombosis of the dorsal penile artery or vein
  12. No known history of coagulation disorder
  13. No known history of stroke, bleeding, or another significant medical conditional which the investigator deems makes the subject unsuitable for enrollment in the study
  14. Testosterone level lower than 500
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04231422


Contacts
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Contact: Judson Brandeis, MD 510-587-3000 Judson@BrandeisMD.com

Locations
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United States, California
BrandeisMD Recruiting
San Ramon, California, United States, 94583
Contact: Judson Brandeis, MD    510-587-3000    Judson@BrandeisMD.com   
Sub-Investigator: Scott Lu         
Sponsors and Collaborators
Judson Brandeis
Investigators
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Principal Investigator: Judson Brandeis, MD BrandeisMD
More Information
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Responsible Party: Judson Brandeis, Principal Investigator, BrandeisMD
ClinicalTrials.gov Identifier: NCT04231422    
Other Study ID Numbers: BRAND-003
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Judson Brandeis, BrandeisMD:
platelet-rich plasma